Clinical Trial Associate

Arbro Pharmaceuticals; Gurugram District; On-site; INR 6,00,000 - 10,00,000; Full time

Job summary

A leading pharmaceutical company in Gurugram is seeking a dedicated professional for clinical study monitoring and site management. Responsibilities include conducting site visits, ensuring compliance with study protocols, training site staff, and maintaining documentation. Ideal candidates should have experience in clinical trials and strong communication skills. This position offers the opportunity to work closely with investigators and contribute to essential trial progress.

Qualifications

• Experience in monitoring clinical trials.
• Knowledge of GCP guidelines and regulatory requirements.
• Strong communication skills and ability to build relationships.

Responsibilities

• Conduct site initiation, routine monitoring, and close-out visits.
• Ensure adherence to study protocol and GCP guidelines.
• Train investigators and site staff on study procedures.

Job description

Role & responsibilities

. Study Monitoring

• Conduct site initiation, routine monitoring, and close-out visits.
• Ensure adherence to study protocol, GCP guidelines & regulatory requirements.
• Verify informed consent forms and ensure ethical compliance.
• Review and validate source documents, CRFs, and eCRF entries.
• Identify protocol deviations and ensure corrective actions are implemented.

2. Site Management

• Train investigators, coordinators, and site staff on study procedures.
• Maintain oversight of site performance and subject recruitment status.
• Ensure availability of study supplies, trial materials, and drug accountability.
• Build strong relationships with investigators and site teams.

3. Documentation & Compliance

• Maintain Trial Master File (TMF) and site-level documentation.
• Ensure timely reporting of adverse events (AEs) and serious adverse events (SAEs).
• Prepare monitoring reports and follow-up letters.
• Ensure data integrity and compliance with SOPs, ICH-GCP, CDSCO/EMA/FDA requirements.

4. Coordination & Communication

• Work with project managers, data managers, and medical monitors.
• Participate in investigator meetings and internal team meetings.
• Provide feedback and updates on site status and trial progress.